2018-06-25 Taking advantage of China CFDA priority approval policy, on-site verification to be activated for Gongwin-KY’s lung cancer new drug PTS302

June 25, 2018, Taipei

The lung cancer new drug belonged to Gongwin Biopharm Holdings Co., Ltd. (hereinafter referred to as "Gongwin-KY", stock code: 6617) has significant progress and breakthrough in New Drug Inspection and Registration Review (NDA) at China National Food and Drug Administration (CFDA). According to the public announcement by Center of Food and Drugs Inspection of CFDA on June 22, PTS302, which was already included on the list of priority approval and special approval drugs, and an on-site verification plan for its clinical trial data will start on July 6. Gongwin-KY pointed out that according to the current approval progress, the completion of on-site verification signifies that the drug certification application for PTS302 will cross a huge threshold. At the same time, the company is actively participating in cross-strait respiratory science seminars, with the expectation to promote the launch of new drugs through hospital sales channels in advance, and inject growth momentum for the company's good overall business operation in the future.

Gongwin-KY stated that the new lung cancer drug PTS302 treats central lung cancer severe airway obstruction as the main indication. Under the leadership of Professor Zhong Nan-Shan, the academician of the Chinese Academy of Engineering as well as the authority of respiratory diseases, phase III clinical trials jointly conducted by 16 AAA hospitals were completed in China. According to the administrative procedures for new drugs inspection and registration, PTS302 is currently being transferred to Center of Food and Drugs Inspection of CFDA for review and approval operations. This further strengthens the confidence for PTS302, of which the clinical trial data is superior to existing treatments, to obtain a drug certificate.

Gongwin-KY further stated that in addition to the progress of PTS302 in the review of Chinese drug certification, its PTS100 liver cancer new drug is also recruiting patients for phase II clinical trials in National Taiwan University Hospital. The initial target includes acceptance of 30 Primary liver cancer patients with arterial embolization failure and unable to meet targeted treatment criteria, and the case acceptance will complete in the end of next year to the following year. Gongwin-KY pointed out that PTS100 Phase II clinical trials conducted in cooperation with the National Taiwan University Hospital involves the injection of PTS100 new drugs into liver tumor via percutaneous puncture through image-guidance to directly eliminate cancer cells. This is a minimally invasive targeted chemical ablation technology, and it is expected to fill the prime treatment needs of patients before liver cancer worsens, to bring brand new treatment opportunities for liver cancer patients.

Media Contact:
Pierre Hsiao, Assistant GM, Gongwin Biopharm (02)2503-5282
Assistant Manager, Ning Deng, IR Trust (02)2585-5705/0911-705-207

About Gongwin:
Gongwin Biopharm Holdings Co., Ltd. (stock code: 6617), founded in 2014, is a Taiwan-based biotechnology pharmaceutical company which focuses on the development of small molecule anti-cancer chemical ablation new drugs. Gongwin-KY steps away from traditional cancer treatment thinking, combines with minimally invasive surgery, and develops new anticancer drugs with PTS as the main active ingredient, providing cancer patients an option to directly eliminate tumors. PTS’s new drug development began in the 1980s. After years of research, in 2011, the inventors John Wu and Dr. Shi Jia-Shun completed Phase III clinical trial of PTS-302 new drug applied on non-small cell lung cancer in China. They also accelerated the application for a drug certificate from China CFDA.

In view of the maturity and energy of Taiwan's R&D environment and its global layout consideration, PTS International Inc. established Gongwin Biopharm and Gongwin Biopharm Holdings, respectively, in Taiwan in 2014, and completed the integration and restructuring in December 2015. Based in Gongwin Biopharm, a subsidiary of Gongwin Holdings, as its operational headquarters, it promotes the Group's global new drug research and development, clinical research, manufacturing technology, international licensing and marketing planning and promotion, truly based in Taiwan and looking out to the whole world.

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